EU legislation on pharmaceutical products for human use also applies in general to traditional herbal medicines. However, in order to overcome difficulties encountered by Member States in applying pharmaceutical legislation to traditional herbal medicinal products in a uniform manner, a simplified registration procedure was introduced in 2004.
General Information
The simplified procedure was introduced by Directive 2004/24/EC
of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
A brief description of the procedure is available under point 3.4 of the Notice to Applicants Volume 2A – Procedures for marketing authorisation, Chapter 1 – Marketing Authorisation.
The simplified registration procedure aims to safeguard public health, remove the differences and uncertainties about the status of traditional herbal medicinal products that existed in the past in the Member States and facilitate the free movement of such products by introducing harmonised rules in this area.
Herbal medicinal products are defined as any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.
This simplified registration procedure is intended for herbal medicinal products with a long tradition, which do not fulfil the requirements for a marketing authorisation, in particular those requirements whereby an applicant can demonstrate by detailed references to published scientific literature that the constituent or the constituents of the medicinal products has or have a well-established medicinal use with recognised efficacy and level of safety (so-called “well established use”).
The simplified procedure allows the registration of herbal medicinal products without requiring particulars and documents on tests and trials on safety and efficacy, provided that there is sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the Community.
With regard to the manufacturing of these products and their quality, applications for registration of traditional herbal medicinal products have to fulfil the same requirements as applications for a marketing authorisation.
In view of the particularities of herbal medicinal products, a Committee for Herbal Medicinal Products (HMPC) has been established at the European Medicines Agency. A major task for the HMPC is to establish Community monographs for traditional herbal medicinal products, and, with the objective of further facilitating registration and harmonisation in the field of traditional herbal medicinal products, prepare a draft list of herbal substances which have been in medicinal use for a sufficiently long time, and hence are considered not to be harmful under normal conditions of use.
List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
With a view to further facilitating the registration of certain traditional herbal medicinal products in the EU, a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products has been established on the basis of the scientific opinion of the HMPC. As regards the safety and efficacy of a traditional herbal medicinal product, applicants can refer to the list. However they would still need to demonstrate the quality of the medicinal products they seek to register.
The list was established by Commission Decision 2008/911/EC of 21 November 2008 .
The decision has been amended to include:
- ‘Calendula officinalis (L.)’ and ‘Pimpinella anisum (L.)’
- ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’
- ‘Mentha x piperita L.’
- Hamamelis virginiana L.’
- ‘Thymus vulgaris L’ and ‘Thymus zygis Loefl. ex L’
- ‘Vitis vinifera L’.
All documents in all available languages >>
Commission implementing decision of 3 February 2012 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
-
Commission implementing decision of 3 February 2012 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 7 February 2012. This decision includes ‘Vitis vinifera L’. in the list of herbal substances.
The text of the decision is available here.
Commission implementing decision of 3 February 2012 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
-
Commission implementing decision of 3 February 2012 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 7 February 2012. This decision includes ‘Thymus vulgaris L’ and ‘Thymus zygis Loefl. ex L’ in the list of herbal substances.
The text of the decision is available here.
Commission implementing decision of 28 November 2011 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
-
Commission implementing decission of 28 November 2011 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 2 December 2011. This decision includes ‘Hamamelis virginianaL.’ in the list of herbal substances.
The text of the decision is available here.
Commission decision of 25 March 2010 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
-
Commission Decision of 25 March 2010 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 26 March 2010. This decision includes ‘Mentha x piperita L.’ in the list of herbal substances.
The text of the decision is available here.
Commission decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
-
Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 19 January 2010. This decision includes ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’ in the list of herbal substances.
The text of the decision is available here
Commission decision of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
-
Commission Decision of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 16 January 2010. This decision includes ‘Calendula officinalis (L.)’ and ‘Pimpinella anisum (L.)’ in the list of herbal substances.
The text of the decision is available here.
DRUG REGULATORY AFFAIRS INTERNATIONAL 